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ElevateBio

ElevateBio

Powering the creation of cell & gene therapies at a speed the world deserves.

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    Basecamp
    Manufacturing & Development Services Overview

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  • cGMP Manufacturing and Automation
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basecamp

cGMP Manufacturing and Automation

cGMP manufacturing solutions across the entire cell and gene therapy product lifecycle.

// Manufacturing &
Development Services

Manufacturing Your Vision

Our BaseCamp® cGMP manufacturing facility in Waltham, MA is built with multiple segregated manufacturing suites for cell therapy products, viral vectors, and mRNA, designed with flexibility to support development and commercial production needs.

  • Our cell therapy, viral vector, and mRNA manufacturing platforms tap into the technology, regulatory and scale-up expertise required for cell and gene therapy development.
  • We can support mRNA drug substance and drug product manufacturing, for any stage of development.

Our Full Spectrum of cGMP Production Solutions

We provide the high-quality scaled manufacturing necessary for cell therapy and viral vectors, including lentiviral vectors and adeno-associated viral (AAV) vectors.

All We Support

  • Lentiviral gene therapies
  • AAV gene therapies
  • TCR-T- and CAR-T cells
  • Engineered treg cells
  • Engineered B cells
  • Gene edited HSCs
  • Allogenic T cell therapies
  • mRNA vaccines
  • mRNA therapeutics in vivo gene editing
  • iPSC-derived cell therapies

Learn more about

Clinical and Commercial Manufacturing
Technology Transfer
Process Validation
Supply Chain Management
CMC Compliance and Regulatory Affairs
Clinical and Commercial Manufacturing

Clinical and Commercial Manufacturing

Our manufacturing process is designed to accelerate and optimize the development of cell and gene therapies. With all the necessary manufacturing expertise and capacity under one roof, we can rapidly transition from preclinical processes to cGMP manufacturing for clinical development and commercialization.

Our purpose-built, multi-product BaseCamp facilities are designed to support autologous cell therapies, allogeneic cell therapies, iPSCs and viral vectors – we can meet you where you are in the process.

Technology Transfer

Technology Transfer

Our dedicated team can rapidly – and seamlessly – transfer your knowledge, processes, specifications, and data into cGMP manufacturing processes for clinical and commercial production. Our systematic technology transfer process enables us to safeguard your program timelines and quickly implement cGMP production based on your custom processes or our platform technologies.

Your success is our success, and our team is ready to work with you to identify process optimization opportunities and incorporate process improvement during product development lifecycle.

Process Validation

Process Validation

With our team of experts and their deep experience in cell and gene therapy commercialization, we can help you achieve the consistent production required for cell and gene therapies.

As products move through development towards commercial launch, we continually provide commercial readiness support through process validation activities and a robust system of analytics and release testing, so your product achieves the necessary quality and quantity, reliably.

Supply Chain Management

Supply Chain Management

Cell and gene therapy manufacturing processes are complex and supply chain management is even more so – which is why we provide our robust and streamlined supply chain management service.

Our validated Chain of Identity and Chain of Custody processes provide ‘needle to needle’ support for donor/patient materials and maintains traceability through apheresis, sample receipt, storage, manufacturing, and delivery of products from start to finish. We partner with you to streamline efforts and ensure we manufacture your product as quickly and efficiently as possible.

CMC Compliance and Regulatory Affairs

CMC Compliance and Regulatory Affairs

BaseCamp provides the necessary Chemistry, Manufacturing and Controls (CMC) functions, all under one roof. Our regulatory experts have a deep understanding of the cell and gene therapy regulatory pathways and are involved in every stage of your product development lifecycle to provide regulatory support based on your program needs.

Partner with ElevateBio®

Wherever you are in your cell and gene therapy product lifecycle, we can strengthen and accelerate the development of your transformative therapies with our enabling technologies and unmatched manufacturing capabilities.

Work with Us

// Work with us

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    • End-to-End Capabilities Overview
    • cGMP Manufacturing and Automation
    • Process Development
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    • Next-Generation Sequencing
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    • ElevateBio BaseCamp Certifications and Compliance
    • Modalities Powered by ElevateBio
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